BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Camera, ophthalmic, ac-powered

    Reg #: 2027009 · FEI: 2027009 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    KARL STORZ IMAGING, INC.
    Registration Number
    2027009
    FEI Number
    2027009
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 S Los Carneros Rd
    City
    Goleta
    State
    CA
    ZIP
    93117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K963333

    Owner / Operator

    Firm Name
    KARL STORZ SE & CO KG
    Operator Number
    8010119
    Address
    Dr.-Karl-Storz-Strasse 34,
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE

    Products

    Device Name Product Code
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Camera, Ophthalmic, Ac-Powered HKI

    Proprietary Names

    Camera, ophthalmic, ac-powered

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)